China-based biopharmaceutical company Innovent Biologics has entered a strategic collaboration with Jiangsu Aosaikang Pharmaceutical (Ask Pharm), focused on limertinib.
Limertinib is an orally administrated, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed by Ask Pharm for the treatment of lung cancer.
Under the partnership agreement, Innovent will obtain exclusive rights to market the drug in mainland China and will receive a service fee based on the product’s net sales in the region.
As the marketing authorisation holder (MAH), Ask-Pharm will be responsible for the production and supply of limertinib and will receive upfront, regulatory and sales milestone payments.
Innovent founder, chairman and CEO Michael Yu said: “We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent’s leadership in oncology.
“The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer.
“Innovent remains committed to investing in innovation and collaborative partnerships, aiming to enhancing the accessibility and affordability of innovative therapies in China to benefit even more patients.”
ASK Pharm’s two New Drug Applications (NDAs) for limertinib, have been accepted and are under review by China’s National Drug Administration (NMPA).
The first NDA is for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed after EGFR TKI therapy.
The second one is for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.
In a multi-centre Phase 3 clinical trial, limertinib showed efficacy and safety that were compared with gefitinib in the first-line treatment of patients with EGFR mutation-positive NSCLC.
ASK Pharm director and general manager Jingfei Ma said: “We are pleased to form a strategic partnership with Innovent Biologics. Limertinib, ASK Pharm’s first innovative drug, targets the cancer type with the highest incidence and mortality rates in China.
“Innovent has a rich product pipeline in the field of lung cancer, which can form advantageous synergies with limertinib.
“In addition, with Innovent’s professional and efficient marketing team and proven commercialisation capabilities, we are confident that this cooperation will help limertinib to fully realise its clinical value, so that more patients can benefit from it.”
